Kornimate/medical-research-clean huggingface dataset:
long term safety of immediate-release tolvaptan in subjects with autosomal dominant polycystic kidney disease

Conditions: Polycystic Kidney, Autosomal Dominant

Summary: the purpose of the trial was to evaluate and describe the long term safety of tolvaptan in participants with autosomal dominant polycystic kidney disease (adpkd).

this was a phase 3b trial to evaluate and describe the long term safety of tolvaptan treatment in adpkd participants with chronic kidney disease (ckd). eligible participants could enroll into trial 156-13-211 after completing the follow-up visit(s) of their previous trial (156-13-210, 156-08-271, 156-04-251, or 156-09-290). renal function was assessed during screening by using historical laboratory values for serum creatinine levels to calculate the estimated glomerular filtration rate (egfr).

Eligibility criteria:
inclusion criteria: * male and female participants ≥ 18 years with confirmed diagnosis of adpkd (during participation in prior tolvaptan trials) who have completed and transferred from the double-blind trial 156-13-210 (12-month period including post treatment follow-up, regardless of whether this was on-treatment or off-treatment), or completed trial 156-08-271 or a prior tolvaptan trial, or interrupted or discontinued treatment in a prior tolvaptan adpkd trial other than trial 156-13-210. participants may be enrolled with the medical monitor approval, and additional close monitoring may be required at the beginning of the trial. * egfr ≥ 20 milliliter (ml)/minute (min)/1.73 meter squared (m\^2) within 3 months prior to the baseline visit. participants who have an egfr ≤ 20 ml/min/1.73 m\^2 may be enrolled with medical monitor approval. exclusion criteria: * need for chronic diuretic use * hepatic impairment based on liver function abnormalities other than that expected for adpkd with cystic liver disease * women of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of investigational medicinal product (imp) * women who are breast-feeding and/or who have a positive pregnancy test result prior to receiving imp. * participants with contraindications to required trial assessments (contraindications to optional assessments, for example, magnetic resonance imaging \[mri\] are not a limitation). * participants who in the opinion of the investigator or the medical monitor, have a medical history or medical finding inconsistent with safety or trial compliance

Keywords: adpkd
comparison of sbrtand repeat tace for hcc

Conditions: HepatoCellular Carcinoma

Summary: comparison of stereotactic body radiation therapy (sbrt) and repeated transarterial chemoembolization (tace) for hepatocellular carcinoma (hcc)as a local salvage treatment after first incomplete tace

the aim of this study is to evaluate the effect of sbrt after first incomplete tace. in hcc patients with incomplete tace response, repeated tace did not showed good response. in this case, sbrt could have better results than tace.

Eligibility criteria:
inclusion criteria: * age \>18 years * eastern cooperative oncology group(ecog) score 0 to 2 * primary hcc * hcc (single nodule ≤ 7 cm or max 3 nodules ≤ 3 cm) * child-turgottei-pugh a or b * unresectable lesion or medically contraindicated surgery or a case in which surgery was declined. * no evidence of radiologically definable major vascular invasion or extrahepatic disease * previously incomplete tace with radiologically defined residual disease after first tace * informed consent exclusion criteria: * prior tace to the target lesion * contraindication to receiving radiotherapy or tace * decompensated liver cirrhosis * extrahepatic mets * pregnancy * patients with other cancers

Keywords: tace sbrt
early administration of fibrinogen in polytraumatized patients with hypofibrinogenemia: a randomized feasibility trial

Conditions: Trauma; Bleeding Disorder; Fibrinogen; Deficiency, Acquired

Summary: this is a randomized feasibility trial conducted with severe trauma patients. at admission patients presented hypofibrinogenemia, hypotension and tachycardia. the primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization. the treatments regards to receive or not to receive an early replacement of fibrinogen.

this is a randomized feasibility trial conducted between december 2015 and january 2017 with severe trauma patients (index of shock severity \[iss\] ≥ 15) admitted to the emergency room of a large trauma center. at admission patients presented qualitative hypofibrinogenemia (fibtem a5 ≤ 9 mm), hypotension (systolic blood pressure \ 100 bpm). the primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization meaning receive replacement through fibrinogen concentrate (50mg per kg of body weight) by the intervention group and not to receive an early replacement of fibrinogen by control group.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 years * severe trauma patients (index of shock severity \[iss\] ≥ 15) * hypotension (systolic blood pressure \< 90 mmhg) * tachycardia (heart rate \> 100 bpm) * qualitative hypofibrinogenemia (fibtem a5 ≤ 9 mm) exclusion criteria: * patient or family do not agree to sign the informed consent form * eligible for institutional massive transfusion protocol * pregnant * previous coagulopathy disorders * use of anticoagulants drugs and/or platelet anti aggregation drugs (exception for aspirin) * previous thromboembolic disorders or events * cardiopulmonary arrest before hospital admission * patient admitted after another hospital transfer * time from trauma to screening above six hours * patients with exclusively traumatic brain injury

Keywords: trauma coagulopathy fibrinogen fibrinogen concentrate thromboelastometry hypofibrinogenemia early fibrinogen replacement
oct in retinal vein occlusions

Conditions: Retinal Vein Occlusions

Summary: retinal blood vessel disease encompasses a wide variety of vision-threatening conditions. of these conditions, retinal vein occlusions are the most common. vision loss can occur as a result of macular ischemia (loss of blood flow to the macula) or macular edema (fluid build-up at the macula). oct is an imaging technology that can perform non-contact cross-sectional imaging of retinal and choroidal tissue structures in real time. it is similar to ultrasound imaging, except that oct measures the intensity of reflected light rather than sound waves. the purpose of this study is to see if non-invasive oct technology can changes due to retinal vein occlusions as well as the more invasive fluorescein angiography, which requires an injection of dye into the vein of an arm of a patient. the study will also compare the mapping of blood vessels (angiography) and loss of blood flow (ischemia) by fluorescein angiography and oct. these studies will be evaluated to see how they relate to vision loss.


Eligibility criteria:
inclusion criteria: * diagnosis of branch or central retinal vein occlusion exclusion criteria: * inability to give informed consent * inability to complete study tests within a 30 day period from date of enrollment * significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant * a prior history of reaction to fluorescein or other dyes. * a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control). * blood pressure \> 180/110 (systolic above 180 or diastolic above 110). if blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible. * systemic anti-vegf or pro-vegf treatment within 4 months prior to treatment. * women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months due to unknown safety of fluorescein angiography. * prior prp or focal laser that would alter the macular perfusion and retino-vascular features. * inability to maintain fixation for oct imaging. * other ocular condition is present such that, in the opinion of the investigator, may alter the retinal perfusion. * an ocular condition is present that, in the opinion of the investigator, might affect or alter visual acuity during the course of the study (e.g., cataract). * substantial cataract that, in the opinion of the investigator, is likely to decrease visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 20/40 or worse if the eye was otherwise normal). * media opacity or otherwise that would prevent either fixation or ability to obtain adequate images as determined by the examiner. * history of major ocular surgeries (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within 4 months prior to enrollment.

Keywords: retinal vein occlusion oct optical coherence tomography imaging
evaluation of a new regional organization to promote access to renal transplantation

Conditions: Renal Failure

Summary: patients with terminal chronic kidney disease (crd) need renal function supplementation, namely dialysis or renal transplantation. transplantation is the most efficient and cost-effective treatment. early and equitable access to transplantation is a public health issue. access to transplantation is facilitated by early and systematic information and assessment of patients for inclusion in the national waiting list for transplantation prior to the onset of dialysis, and by the development of transplantation from living donors. in france, there are wide disparities in access to national waiting list registration and transplantation. one of the causes of these inequalities in access would be the disparity in referral practices to a transplant medical and surgical team authorized to register the individual on the national waiting list. the aim of the trace study is to evaluate the impact of a new regional organization promoting renal transplantation on access to renal transplantation.


Eligibility criteria:
inclusion criteria: * patient older than 18 years and younger than 85 years. * entered in the french network epidemiology and information in nephrology register * renal function supplementation begun in 2013 -- 2014 (period before regional organization implementation) or in 2018 -- 2019 (period after regional organization implementation). exclusion criteria: - patient followed in a center of nephrology-dialysis or of renal transplantation located outside french auvergne rhône alpes or center regions.
aed/statin interaction study

Conditions: Epilepsy

Summary: this study will evaluate the amount of the cholesterol-lowering drug atorvastatin available in the bloodstream, when taken together with the anti-seizure drugs lamotrigine or phenytoin.


Eligibility criteria:
key inclusion criteria: * body weight \>50kg (men) or \>45kg (women) and bmi within the range 19-32 kg/m2 inclusive. * no clinically significant abnormality on clinical examination key exclusion criteria: * history or evidence of drug or alcohol abuse or active tobacco use. * women of childbearing potential * use of prescribed or non-prescribed medications during and within 14 days of starting study medication.

Keywords: drug interaction pharmacokinetics healthy volunteers
the effect of esophageal doppler guided goal-directed hemodynamic therapy in severe trauma patients

Conditions: Trauma

Summary: prospective randomized clinical trial compare the goal-directed fluid therapy using esophageal doppler and classic fluid therapy

goal directed fluid therapy becomes issue for enhanced recovery after surgery. in goal directed therapy, dynamic parameters, like stroke volume and cardiac output, is important. esophageal doppler is one of device which provides dymanic parameters. in severe trauma cases, the effect of goal directed therapy is not known yet. so the aim of this study is comparing the results of goal directed therapy using esophageal doppler and conventional fluid therapy.

Eligibility criteria:
inclusion criteria: * severe trauma patients who undergo general anesthesia * initial serum lactate level \> 2mmol/l exclusion criteria: * severe traumatic brain injury * thoracic surgery * age \< 19 years old * impending arrest or post cpr state * severe facial trauma
assessment of low-dose asa discontinuation risk associated with concomitant ppi use during the first year of asa therapy

Conditions: Cardiovascular Prevention

Summary: this study is conducted in a cohort of low dose aspirin (asa) users previously ascertained .the aims of the post hoc analyses are: to estimate the one year risk of discontinuation of use of low-dose asa associated to ppi concomitant use versus non-use, crude and adjusted by confounding. to estimate the one year risk of discontinuation of use of low-dose asa associated to ppi concomitant use stratified by age and sex. to evaluate other predictors of discontinuation of low-dose asa during the first year of asa therapy.

assessment of low-dose asa discontinuation risk associated with concomitant ppi use during the first year of asa therapy for secondary prevention

Eligibility criteria:
inclusion criteria: * patients aged 50-84 years in 2000-2007. * patients with first prescription of low dose asa ( see study population description). * patients were required to have been enrolled with their primary care practitioner (pcp) for at least 2 years and to have a computerized prescription history of at least 1 year before the start of the study. exclusion criteria: * patients aged below age 50 and 85 years and above ( see study population description). * patients with a diagnosis of cancer, alcohol abuse or alcohol-related disease. * incomplete data recording in thin.

Keywords: discontinuation of low dose asa, secondary cardiovascular prevention, acid-suppressing drugs, gastrointestinal risk, epidemiology
pharmacodynamic comparison of truncal blocks in patients with or without metabolic disease (kidney failure, diabetes)

Conditions: Renal Insufficiency; Diabetes

Summary: the primary objective is to demonstrate a longer period of neurologic recovery from a sensory block assessed in each test group versus the group without metabolic disease.


Eligibility criteria:
general inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 1 month of follow up * the patient is scheduled for hand or wrist surgery inclusion criteria for the "renal insufficiency" group * patient has renal insufficiency as defined by a creatine clearance of \< 30ml/min without dialysis inclusion criteria for the "diabetes" group * patient has chronic hyperglycemia, either a fasting glycemia \> 1.26 g/l (7mmol/l) for longer than 5 years and receiving an oral, well-adjusted (last hba1c \< 6.5%)), non-insulin, antidiabetic treatment inclusion criteria for the "non-exposed" group * patient without metabolic or neurologic disease, with creating clearance \> 90ml/min exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant * the patient is breastfeeding * patient weighs less than 50 kg * score asa \> 4 * contra indication for locoregional anesthesia * severe metabolic and / or decompensated renal disease, cardiac or pulmonary decompensation * associated peripheral neuropathy associated with diabetes or kidney disease * associated central neuropathy associated (eg ms ... narrow cervical canal) * patients with both renal failure and diabetes
cardiac rehabilitation and low frequency electrical myostimulation in chronic heart failure

Conditions: Chronic Heart Failure

Summary: the purpose of this study is to determine if addition of low frequency electro-myo-stimulation to cardiac rehabilitation is effective to improve exercise capacity and/or muscular strength in chronic heart failure patients.

in chronic heart failure, low exercise capacity is due, in part, to peripheral muscles abnormalities. exercise training performed during cardiac rehabilitation improves exercise tolerance measured by cardiopulmonary exercise test. low frequency electromyostimulation (ems) was proposed as an alternative to exercise training (et) in this population. however, the effectiveness of the combination (ems +et) compared with et alone is not proved. the main objective is to compare exercise capacity judged by peak vo2 after treatment by et alone versus ems+et. the secondary end points are results on sub maximal parameters, muscular resistance, quality of life and effectiveness regarding clinical sub-groups. this study is a controlled, randomized, multicentric (14 centres) designed to include 90 patients by group in two years period. inclusion criteria are: chf patients , nyha class ii to iiib, with lvef \< 40% referred to complete a cardiac rehabilitation program. all the patients benefit from a comprehensive cardiac rehabilitation program including educational program, therapeutical optimisation and exercise training for 20 sessions, 3 to 5 days a week. the group of patients randomized for additional ems has 20 sessions of 1 hour electrical quadricipital myostimulation.

Eligibility criteria:
inclusion criteria: * age from 18 to 75 yo * stable chronic heart failure (chf) under "optimal" treatment since at least 1 week * nyha functional class ii to iiib * left ventricular ejection fraction \< 40% * cardiopulmonary exercise test feasible * whatever etiology of heart failure * age of heart failure ≥ 3 months. * have signed the consent document to participate in the study exclusion criteria: * previous treatment by functional electrical myo stimulation * recent acute heart failure or inotropic intravenous agents used (\< 10 days) * recent coronary angioplasty (\< 10 days) * cardiac surgery \< 1 month * valvular disease requiring surgical treatment * uncontrolled hypertension (≥ systolic 180 and/or diastolic 110 mmhg) * severe respiratory insufficiency (vems \< 1000 ml) * pregnancy * automatic implantable defibrillator * pace-makers : cardiac stimulation dependence or not known * incapacity to achieve 6 min walk test and/or exercise testing * absolute contra-indication to exercise test and/or exercise training * myocarditis or pericarditis * uncontrolled ventricular arrhythmias * obesity (bmi ≥ 35) * known and documented peripheral myopathy * participation to another study protocol * patient incapable of giving consent

Keywords: chronic heart failure cardiac rehabilitation exercise training peak vo2 electrical myostimulation
efficacy of prednisolone versus cerebrolysin in the treatment of bell's palsy

Conditions: Bell Palsy

Summary: bell's palsy, a peripheral facial nerve paresis, is the most common disorder of the facial nerve and one of the most common mononeuropathies. many patients with bell's palsy will develop some complications such as synkinesis, crocodile tears and 'sweating' of the ear while eating commonly used medications to treat bell's palsy is corticosteroids cerebrolysin stimulates the regeneration of the nervous tissue with protective action we aim to study the efficacy of cerebrolycin in bell's palsy


Eligibility criteria:
inclusion criteria: * unilateral acute facial palsy of no identifiable cause exclusion criteria: * recurrent facial bell's palsy * pregnancy * diabetes * epilepsy * severe hypertension, * renal or hepatic disease, * gastric or duodenal ulcer * presence of acute otitis media or ipsilateral chronic otitis * recent head injury, * psychiatric disease * if there is any contraindications for corticosteroids
cholecystitis in villavicencio hospitals

Conditions: Biliary Tract Diseases

Summary: background: acute cholecystitis is a frequent cause of visits to the emergency ward. the complications of delays in attention and surgical therapy are substantial and should be considered to prevent them timely. objective: the study aims to evaluate the assistance provided to patients for cholecystitis in villavicencio hospitals. methodology: a retrospective cross-sectional trial will be performed. the source of information will be the surgical database of hospitals at villavicencio from 2019 to 2022. the records selected will be exported to an excel spreadsheet for debugging and analysis. the central distribution and dispersion of numerical variables will be analyzed, as frequency and proportion of categorical variables with the software prism 10.01.1 for mac ios. chi-square and u-mann \& whitney tests will compare variables according to the data type. a p\<0.05 will be defined as statistically significant. expected results: the researchers hope to define the frequency of hospital discharges due to acute cholecystitis, the type of procedure performed, complications, and outcomes. conclusions: the research is feasible because the necessary information is available for evaluation, and it is helpful for the institutions and the region.

biliary diseases are some leading causes of admission to emergency wards. cholelithiasis and acute cholecystitis are prevalent in the orinoquia region. young and female populations are predominantly affected. complications are prone to delayed definitive surgical therapy, which increases costs and the use of resources. guidelines recommend early surgery during hospitalization for the first episode to minimize difficulties. there are limitations in the available technology recommended for treatment, especially in institutions dedicated to vulnerable populations. laparoscopic cholecystectomy is the primary goal in cases required for gall bladder removal. although the technology and trained personnel are available in local institutions, open procedures are still performed primarily, and restrictions are due to insurance coverage after more than 30 years of disseminating laparoscopic cholecystectomy worldwide. it is necessary to know the prevalence of the disease and the therapy provided in general hospitals from the region to analyze associated factors with undesired results. determining the characteristics of patients admitted to hospitals by biliary pathology will provide essential information on the severity, care provided, definitive treatment, opportunity, and outcomes. such an analysis will give knowledge to prioritize policies and resources, upgrade clinical practice guidelines, and improve early and long-term results.

Eligibility criteria:
inclusion criteria: * patients admitted with acute or chronic biliary pathology. exclusion criteria: * none.

Keywords: acute cholecystitis gallbladder diseases cholecystolithiasis biliary tract surgical procedures laparoscopy conversion to open surgery hospital surgery department colombia